NCT00313612

Oxaliplatin and Topotecan in Advance Ovarian Cancer

A Phase II Study of Oxaliplatin Combined With Continuous Infusion Topotecan as Chemotherapy for Patients With Previously Treated Ovarian Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as oxaliplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. Estimate the overall clinical response rate (complete and partial responses) in patients with previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with oxaliplatin and topotecan. II. Determine the toxic effects in patients treated with this regimen. SECONDARY OBJECTIVES: I. Estimate the time to progression and overall clinical response duration in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients are stratified according to response to prior platinum therapy (resistant vs sensitive). Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.

Conditions

• Recurrent Ovarian Epithelial Cancer

Interventions

Type	Name	Description
DRUG	oxaliplatin	Given IV
DRUG	topotecan	Given IV

Timeline

• Start date: 2006-01-01
• Primary completion: 2011-05-01
• Completion: 2012-12-01
• First posted: 2006-04-12
• Last updated: 2015-11-27
• Results posted: 2015-11-27

Locations

2 sites across 1 country: United States